# China NMPA Product Recall - Follicle-stimulating hormone (FSH) assay kit (chemiluminescence immunoassay); FSH calibrator; Total human chorionic gonadotropin (hCG) B subunit || Calibrator (chemiluminescence immunoassay); Total human chorionic gonadotropin (hCG) subunit | Assay kit (chemiluminescence immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/1a97f64e-71cb-4edb-989d-f97725948404/
Source feed: China

> China NMPA product recall for Follicle-stimulating hormone (FSH) assay kit (chemiluminescence immunoassay); FSH calibrator; Total human chorionic gonadotropin (hCG) B subunit || Calibrator (chemiluminescence immunoassay); Total human chorionic gonadotropin (hCG) subunit | Assay kit (chemiluminescence immunoassay) by Ortho-Clinical Diagnostics, Inc. published August 29, 2016. Recall level: Level III. Ausendo Medical Devices Trading (China) Co., Ltd., acting on behalf of manufacturer Ortho-Clinical D

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling the following products: Follicle-stimulating hormone (FSH) assay kit (chemiluminescence method), FSH calibrators, Total Human Chorionic Gonadotropin (HCG) β Subunit II calibrators (chemiluminescence method), and Total Human Chorionic Gonadotropin (HCG) β Subunit II assay kit (chemiluminescence method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2016-08-29
- Product Name: Follicle-stimulating hormone (FSH) assay kit (chemiluminescence immunoassay); FSH calibrator; Total human chorionic gonadotropin (hCG) B subunit || Calibrator (chemiluminescence immunoassay); Total human chorionic gonadotropin (hCG) subunit | Assay kit (chemiluminescence immunoassay)
- Recall Level: Level III
- Recall Reason: Due to changes to the product registration certificate, specifically a change in the manufacturer's registered address (not the production address) and the change of the Chinese agent, the product's identification information is inconsistent with the registration certificate information.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., acting on behalf of manufacturer Ortho-Clinical Diagnostics, initiated a voluntary Level III recall in China. The recall, reported to the National Medical Products Administration (NMPA) on June 6, 2016, and publicly announced on August 29, 2016, involved several in vitro diagnostic products. These included Follicle-Stimulating Hormone Assay Kits and Calibrators, and Total Human Chorionic Gonadotropin B Subunit II Assay Kits and Calibrators. The core issue stemmed from a regulatory compliance violation: the product's identification information was inconsistent with its official registration certificate. This discrepancy arose because changes to the manufacturer's registered address and its designated Chinese agent were not properly reflected on the product documentation. This situation, while not impacting product performance or safety, represented a failure to maintain accurate and updated regulatory details. Under the NMPA framework, Ausendo Medical Devices Trading (China) Co., Ltd. has committed to informing all distributors and hospital clients affected by the recall. Additionally, the company is implementing corrective actions for all unused products to ensure their identification aligns with the current registration certificate information. This proactive measure underlines the company's adherence to regulatory standards for medical device identification and registration within China.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/